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NCT Number: NCT07683065

A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD

This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis [PsA]) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine clinical practice in Spain, as well as hepatic biomarker trajectories. The study will use electronic medical record (EMR) data from multiple Spanish hospitals.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a first recorded secukinumab prescription between 01 January 2021 and 31 December 2023.
  • Patients aged ≥18 years at index date.
  • Patients with no prior secukinumab exposure in available EMR history.
  • Secukinumab must be patient's first-, second-, or third-line biologic therapy for psoriasis/psoriatic arthritis (PsA).
  • Patients with documented administration per Summary of Product Characteristics dosing recommendations (SmPC).
  • Patients with confirmed plaque psoriasis with or without PsA.
  • Patients with at least one cardiometabolic risk factor.
  • Patients with a confirmed MASLD diagnosis.
  • Patients with baseline laboratory data available.

Exclusion criteria

  • Patients with evidence of MASLD absence.
  • Patients with malignant liver disease.
  • Patients with a history of liver transplantation.
  • Patients with alcohol use disorder.
  • Patients with other chronic liver diseases.
  • Patients with diseases or treatments which cause thrombocytopenia.
  • Patients with decompensated cirrhosis.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Primary outcomes

  1. Number of Definitive Discontinuation Events Per Patient-Year

    Time frame: Up to 5 years

    Definitive discontinuation is defined as the date of first documentation of secukinumab discontinuation or biologic switch, whichever is recorded first.

Secondary outcomes

  1. Cumulative Incidence of Treatment Discontinuation Due to Lack of Response

    Time frame: Up to 5 years

    Discontinuation due to lack of response is defined as the first documentation of secukinumab discontinuation or biologic switch due to lack of response or similar assessment, whichever is recorded first

  2. Proportion of Patients who Achieve a Psoriasis Area and Severity Index (PASI) 100

    Time frame: 12 and 24 months

    PASI is a combined assessment of lesion severity and affected area into a single score. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a maximum of 72.0. The body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area multiplied by the area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A PASI 100 response corresponds to complete clearing of psoriasis (PASI = 0).

  3. Proportion of Patients who Achieve a PASI Score ≤ 3

    Time frame: 12 and 24 months

    PASI is a combined assessment of lesion severity and affected area into a single score. The body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area multiplied by the area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a maximum of 72.0.

  4. Cumulative Incidence of a ≥20% Relative Increase in Fibrosis-4 Index (FIB-4) From Baseline

    Time frame: Baseline up to 5 years

    FIB-4 is a non-invasive tool used to assess liver fibrosis. The FIB-4 score is calculated using age, aspartate aminotransferase (AST) level, alanine aminotransferase (ALT) level, and platelet count.

    FIB-4 fibrosis risk categories:

    • Low risk: FIB-4 < 1.30
    • Intermediate risk: 1.30 ≤ FIB-4 ≤ 2.67
    • High risk: FIB-4 > 2.67
  5. Proportion of Patients With a Shift in Fibrosis Category

    Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months

    FIB-4 and aspartate aminotransferase to platelet ratio index (APRI) are non-invasive tools used to assess liver fibrosis. The scores are calculated using age, AST level, ALT level, and platelet count

    FIB-4 fibrosis risk categories (patients aged ≥35 years):

    • Low risk: FIB-4 < 1.30
    • Intermediate risk: 1.30 ≤ FIB-4 ≤ 2.67
    • High risk: FIB-4 > 2.67

    APRI risk categories (patients aged <35 years):

    • Low risk: APRI < 0.50
    • Intermediate risk: 0.50 ≤ APRI ≤ 1.50
    • High risk: APRI > 1.50
  6. FIB-4 Score

    Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months

    FIB-4 is a non-invasive tool used to assess liver fibrosis. The FIB-4 score is calculated using age, AST level, ALT level, and platelet count.

    FIB-4 fibrosis risk categories:

    • Low risk: FIB-4 < 1.30
    • Intermediate risk: 1.30 ≤ FIB-4 ≤ 2.67
    • High risk: FIB-4 > 2.67
  7. APRI Score

    Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months

    APRI is a non-invasive tool used to assess liver fibrosis. The APRI score is calculated using AST level and platelet count

    APRI risk categories:

    • Low risk: APRI < 0.50
    • Intermediate risk: 0.50 ≤ APRI ≤ 1.50
    • High risk: APRI > 1.50
  8. AST Level

    Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months

  9. ALT Level

    Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months

  10. Platelet Count

    Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months

  11. Correlation Between Changes in FIB-4 and Changes in PASI

    Time frame: Baseline to 12 and 24 months

    Associations between changes in the level of liver fibrosis (FIB-4) and changes in the severity of psoriasis (PASI) will be explored using Spearman correlations.

  12. Correlation Between Changes in APRI and Changes in PASI

    Time frame: Baseline to 12 and 24 months

    Associations between changes in the level of liver fibrosis (APRI) and changes in the severity of psoriasis (PASI) will be explored using Spearman correlations.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

SEC-HOPE: A Multicenter Retrospective Cohort Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD

Acronym: SEC-HOPE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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